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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
510(k) Number K060039
Device Name INFINITY DELTA AND KAPPA SERIES MONITORS WITH VF6 MODIFICATIONS
Applicant
Draeger Medical Systems, Inc.
16 Electronics Ave.
Danvers,  MA  01923
Applicant Contact KAREN IORIO
Correspondent
Draeger Medical Systems, Inc.
16 Electronics Ave.
Danvers,  MA  01923
Correspondent Contact KAREN IORIO
Regulation Number870.1025
Classification Product Code
MHX  
Date Received01/06/2006
Decision Date 04/12/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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